PregledMedicinski proizvodi i in vitro dijagnostički medicinski proizvodi igraju glavnu ulogu u spašavanju života tako što pružaju inovativna zdravstvena…DirektiveU EU-u se trenutačno primjenjuju sljedeće direktive o medicinskim proizvodima: Direktiva 98/79/EZ Europskog parlamenta i VijećaNovi propisiEU je revidirao zakonodavne akte o medicinskim proizvodima i in vitro dijagnostici kako bi se uskladio s razvojem sektora u posljednjih 20 godina. Latest updates News announcement12 siječanj 2023MDCG 2023-2 - List of Standard Fees - January 2023News announcement10 siječanj 2023MDCG 2023-1 - Guidance on the health institution exception under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 - January 2023News announcement16 prosinac 2022MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - December 2022News announcement16 prosinac 2022MDCG 2022-4 rev.1 - Guidance on appropriate surveillance regarding MDR Art.120 transitional provisions - devices covered by MDD or AIMDD certificates - December 2022Prikaži sve Highlights News announcement5 kolovoz 2022Call for EU reference laboratories sent to Member StatesBenchmarks for high-risk diagnosticsNews announcement21 lipanj 2022Setting the scene for EU reference labs for high-risk diagnostics26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EUNews announcement24 svibanj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devicesNews announcement26 svibanj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devicesThe UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new systemGetting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities Events 07svi2021Partnerski sastanciWebinar for Patients – Safe and performant Medical Devices for all Documents EventsPublications
PregledMedicinski proizvodi i in vitro dijagnostički medicinski proizvodi igraju glavnu ulogu u spašavanju života tako što pružaju inovativna zdravstvena…
DirektiveU EU-u se trenutačno primjenjuju sljedeće direktive o medicinskim proizvodima: Direktiva 98/79/EZ Europskog parlamenta i Vijeća
Novi propisiEU je revidirao zakonodavne akte o medicinskim proizvodima i in vitro dijagnostici kako bi se uskladio s razvojem sektora u posljednjih 20 godina.
News announcement10 siječanj 2023MDCG 2023-1 - Guidance on the health institution exception under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 - January 2023
News announcement16 prosinac 2022MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - December 2022
News announcement16 prosinac 2022MDCG 2022-4 rev.1 - Guidance on appropriate surveillance regarding MDR Art.120 transitional provisions - devices covered by MDD or AIMDD certificates - December 2022
26 May 2022, the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices is applicable within the EU
News announcement24 svibanj 2022Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices
News announcement26 svibanj 2021Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices
The UDI Helpdesk helps economic operators in the implementation of the requirements introduced by the new system
Getting ready for the new medical devices regulations – Factsheets on the main areas of the medical devices sector activities
